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Breast Cancer Associated Antibodies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Lab Discoveries Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lab Discoveries Ltd.
ClinicalTrials.gov Identifier:
NCT00331942
First received: May 27, 2006
Last updated: March 1, 2007
Last verified: April 2006
  Purpose

To determine the ability of the Cimmunology process to lead to in vitro antibody production, the ability of the ELISA assays to detect any of those antibodies, and to establish the relationship between the ELISA results and the clinical / pathological status of the patient. The statistical significance of the CAAb test results will be determined.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Study of Breast Cancer Associated Antibodies

Resource links provided by NLM:


Further study details as provided by Lab Discoveries Ltd.:

Estimated Enrollment: 100
Study Start Date: July 2006
Estimated Study Completion Date: May 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria BC:

  • Subjects 18 years or over.
  • Patients diagnosed with suspected breast cancer, (positive mammography or ultrasound or physical examination) and have a positive biopsy.
  • Patients willing to participate as evidenced by signing the written informed consent.

Exclusion Criteria BC:

  • Subjects less than 18 years
  • Patients with prior history of other tumors (except skin cancer)
  • Hematologic systemic disorders
  • Patients that have undergone chemotherapy
  • Patients that have been under anesthesia in the last three months.
  • Patient not willing to sign written informed consent.

Inclusion Criteria Control -

  • Subjects 18 years or over
  • Patients willing to participate as evidenced by signing the written informed consent
  • Subjects had a negative mammography in the past three months.

Exclusion Criteria Control -

  • Subjects less than 18 years
  • Hematological malignancies
  • History of any past tumors
  • Other breast pathology
  • Patients that have been under anesthesia in the last three months
  • Patients treated with immuno-suppressant drugs
  • Patient not willing to sign written informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331942

Contacts
Contact: Alon Hayka +972 544 631237 alonhayka@yahoo.com

Locations
Israel
Soroka Recruiting
Beer-Sheva, Israel
Contact: Michal Koretz, Dr.    972 8 6403336      
Carmel Medical center Recruiting
Haifa, Israel
Contact: Pnina Engelman, Dr.    972 4 8787909      
Sponsors and Collaborators
Lab Discoveries Ltd.
Investigators
Principal Investigator: Tamar J Cohen, Phd. Lab Discoveries
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00331942     History of Changes
Other Study ID Numbers: LD-BC-CAAb
Study First Received: May 27, 2006
Last Updated: March 1, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Lab Discoveries Ltd.:
Breast
Cancer
Associated
Antibodies

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014